A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis
Abstract Background This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active rheumatoid arthritis (RA). Methods In this randomized, double-blind, active-controlled, non-inferiority tria...
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| Format: | Article |
| Language: | English |
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BMC
2017-07-01
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| Series: | Arthritis Research & Therapy |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13075-017-1371-4 |
| _version_ | 1828344994022293504 |
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| author | Ahmadreza Jamshidi Farhad Gharibdoost Mahdi Vojdanian Soosan G. Soroosh Mohsen Soroush Arman Ahmadzadeh Mohammad Ali Nazarinia Mohammad Mousavi Hadi Karimzadeh Mohammad Reza Shakibi Zahra Rezaieyazdi Maryam Sahebari Asghar Hajiabbasi Ali Asghar Ebrahimi Najmeh Mahjourian Amin Mohammadinejad Rashti |
| author_facet | Ahmadreza Jamshidi Farhad Gharibdoost Mahdi Vojdanian Soosan G. Soroosh Mohsen Soroush Arman Ahmadzadeh Mohammad Ali Nazarinia Mohammad Mousavi Hadi Karimzadeh Mohammad Reza Shakibi Zahra Rezaieyazdi Maryam Sahebari Asghar Hajiabbasi Ali Asghar Ebrahimi Najmeh Mahjourian Amin Mohammadinejad Rashti |
| author_sort | Ahmadreza Jamshidi |
| collection | DOAJ |
| description | Abstract Background This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active rheumatoid arthritis (RA). Methods In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with active RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA® or Humira® every other week, while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7.5 mg/day) over a period of 24 weeks. Physical examinations, vital sign evaluations, and laboratory tests were conducted in patients at baseline and at 12-week and 24-week visits. The primary endpoint in this study was the proportion of patients achieving moderate and good disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR)-based European League Against Rheumatism (EULAR) response. The secondary endpoints were the proportion of patients achieving American College of Rheumatology (ACR) criteria for 20% (ACR20), 50% (ACR50), and 70% (ACR70) responses along with the disability index of health assessment questionnaire (HAQ), and safety. Results Patients who were randomized to CinnoRA® or Humira® arms had comparable demographic information, laboratory results, and disease characteristics at baseline. The proportion of patients achieving good and moderate EULAR responses in the CinnoRA® group was non-inferior to the Humira® group at 12 and 24 weeks based on both intention-to-treat (ITT) and per-protocol (PP) populations (all p values >0.05). No significant difference was noted in the proportion of patients attaining ACR20, ACR50, and ACR70 responses in the CinnoRA® and Humira® groups (all p values >0.05). Further, the difference in HAQ scores and safety outcome measures between treatment arms was not statistically significant. Conclusion CinnoRA® was shown to be non-inferior to Humira® in terms of efficacy at week 24 with a comparable safety profile to the reference product. Trial registration IRCT.ir, IRCT2015030321315N1 . Registered on 5 April 2015. |
| first_indexed | 2024-04-14T00:05:12Z |
| format | Article |
| id | doaj.art-c0cc6bd790604a3a9491faa9bb596ee8 |
| institution | Directory Open Access Journal |
| issn | 1478-6362 |
| language | English |
| last_indexed | 2024-04-14T00:05:12Z |
| publishDate | 2017-07-01 |
| publisher | BMC |
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| series | Arthritis Research & Therapy |
| spelling | doaj.art-c0cc6bd790604a3a9491faa9bb596ee82022-12-22T02:23:34ZengBMCArthritis Research & Therapy1478-63622017-07-011911910.1186/s13075-017-1371-4A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritisAhmadreza Jamshidi0Farhad Gharibdoost1Mahdi Vojdanian2Soosan G. Soroosh3Mohsen Soroush4Arman Ahmadzadeh5Mohammad Ali Nazarinia6Mohammad Mousavi7Hadi Karimzadeh8Mohammad Reza Shakibi9Zahra Rezaieyazdi10Maryam Sahebari11Asghar Hajiabbasi12Ali Asghar Ebrahimi13Najmeh Mahjourian14Amin Mohammadinejad Rashti15Rheumatology Research Center, Tehran University of Medical SciencesRheumatology Research Center, Tehran University of Medical SciencesRheumatology Research Center, Tehran University of Medical SciencesAJA university of Medical Sciences Rheumatology research centerAJA university of Medical Sciences Internal medicine, Rheumatology SectionDepartment of Rheumatology, Loghman e Hakim Hospital, Shahid Beheshti University of Medical SciencesShiraz Geriatric Research Center, Shiraz University of Medical SciencesDepartment of Rheumatology, School of Medicine, Shahrekord University of Medical Sciences, Shahrekord AND Behcet’s Unit, Rheumatology Research Center, Tehran University of Medical SciencesDepartment of Rheumatology, Al-Zahra HospitalEndocrinology and Metabolism Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical SciencesRheumatic Diseases Research Center, Faculty of Medicine, Mashhad University of medical SciencesRheumatic Diseases Research Center, Faculty of Medicine, Mashhad University of medical SciencesGuilan Rheumatology Research Center, Department of Rheumatology, Razi Hospital, School of Medicine, Guilan University of Medical SciencesTabriz University of Medical Sciences, Connective Tissue Reserch CenterTehran University of Medical SciencesTehran University of Medical Sciences, Faculty of PharmacyAbstract Background This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active rheumatoid arthritis (RA). Methods In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with active RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA® or Humira® every other week, while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7.5 mg/day) over a period of 24 weeks. Physical examinations, vital sign evaluations, and laboratory tests were conducted in patients at baseline and at 12-week and 24-week visits. The primary endpoint in this study was the proportion of patients achieving moderate and good disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR)-based European League Against Rheumatism (EULAR) response. The secondary endpoints were the proportion of patients achieving American College of Rheumatology (ACR) criteria for 20% (ACR20), 50% (ACR50), and 70% (ACR70) responses along with the disability index of health assessment questionnaire (HAQ), and safety. Results Patients who were randomized to CinnoRA® or Humira® arms had comparable demographic information, laboratory results, and disease characteristics at baseline. The proportion of patients achieving good and moderate EULAR responses in the CinnoRA® group was non-inferior to the Humira® group at 12 and 24 weeks based on both intention-to-treat (ITT) and per-protocol (PP) populations (all p values >0.05). No significant difference was noted in the proportion of patients attaining ACR20, ACR50, and ACR70 responses in the CinnoRA® and Humira® groups (all p values >0.05). Further, the difference in HAQ scores and safety outcome measures between treatment arms was not statistically significant. Conclusion CinnoRA® was shown to be non-inferior to Humira® in terms of efficacy at week 24 with a comparable safety profile to the reference product. Trial registration IRCT.ir, IRCT2015030321315N1 . Registered on 5 April 2015.http://link.springer.com/article/10.1186/s13075-017-1371-4AdalimumabBiosimilarCinnoRA®Rheumatoid arthritis |
| spellingShingle | Ahmadreza Jamshidi Farhad Gharibdoost Mahdi Vojdanian Soosan G. Soroosh Mohsen Soroush Arman Ahmadzadeh Mohammad Ali Nazarinia Mohammad Mousavi Hadi Karimzadeh Mohammad Reza Shakibi Zahra Rezaieyazdi Maryam Sahebari Asghar Hajiabbasi Ali Asghar Ebrahimi Najmeh Mahjourian Amin Mohammadinejad Rashti A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis Arthritis Research & Therapy Adalimumab Biosimilar CinnoRA® Rheumatoid arthritis |
| title | A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis |
| title_full | A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis |
| title_fullStr | A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis |
| title_full_unstemmed | A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis |
| title_short | A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis |
| title_sort | phase iii randomized two armed double blind parallel active controlled and non inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab cinnora r to the reference product humira r in patients with active rheumatoid arthritis |
| topic | Adalimumab Biosimilar CinnoRA® Rheumatoid arthritis |
| url | http://link.springer.com/article/10.1186/s13075-017-1371-4 |
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